Department of Psychiatry and Neurochemistry, The Sahlgrenska Academy, University of Gothenburg, Institute of Neuroscience and Physiology, Göteborg and Mölndal, Sweden.
Clin Chem Lab Med. 2010 May;48(5):603-7. doi: 10.1515/CCLM.2010.131.
Abstract Several drug candidates for Alzheimer's disease are being evaluated in clinical trials, with the goal of finding a drug with disease-modifying effects. When such a drug finally reaches the market, there will be a demand for accurate diagnostic tools useful for early detection of disease and for monitoring biochemical effects. The core cerebrospinal fluid (CSF) biomarkers amyloid peptides (Abeta42), total-tau and phospo-tau are promising in this respect. However, inter-center variation (caused by pre-analytical, analytical and post-analytical factors), and inter-laboratory variation (caused by analytical factors), particularly for CSF Abeta42, lowers their utility in multicenter studies. Here, we discuss the causes of these variations, and present a global quality control program to overcome them.
摘要 目前有几种阿尔茨海默病的候选药物正在临床试验中进行评估，以期找到具有疾病修饰作用的药物。当这种药物最终上市时，人们将需要准确的诊断工具来帮助早期发现疾病并监测生化效应。核心的脑脊液（CSF）生物标志物淀粉样肽（Abeta42）、总tau 和磷酸化 tau 在这方面很有前景。然而，中心间的差异（由分析前、分析中和分析后因素引起）和实验室间的差异（由分析因素引起），特别是 CSF Abeta42 的差异，降低了它们在多中心研究中的实用性。在这里，我们讨论了这些差异的原因，并提出了一个全球质量控制计划来克服这些差异。
